NCT06567795

PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG

Prospective, Multi-center, Longitudinal, Study for PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 189 (estimated)
• Sponsor: Aventusoft, LLC. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG.

Detailed description

This is a prospective, multi-center, longitudinal study to evaluate the proportion of cardiovascular events in diabetic mellitus patients identified by HEMOTAG evaluations, utilizing cardiac time interval measurements being treated in outpatient clinics. An enriched diabetic patient population, currently undergoing standard medical care for their diabetes management (per the American Diabetes Association) will be invited to participate within this study. All patients will complete their standard of care assessments including, vital signs, creatinine, eGFR, fasting Cholesterol (including HDL and LDL), HbA1c,and NT-pro BNP, at their regularly scheduled diabetic clinic visits. During the enrollment visit, patients will undergo a baseline HEMOTAG evaluation, cardiovascular event assessment as well as baseline questionnaire assessments. Patients will be shipped a HEMOTAG device with electrodes, and HEMOTAG measurements will be conducted at least three days a week for a 30-day period at-home. This will occur after the Baseline Visit, after the 6-month Visit, and following any hospitalizations due to cardiac events during the 12-month study. All patients will undergo standard of care follow-up visits at their normal 6 month and 12 month visits and will repeat the HEMOTAG evaluation (in clinic), cardiovascular event assessment, NT-pro BNP, as well as questionnaire assessments. Results of standard of care assessments including, vital signs, creatinine, eGFR, fasting Cholesterol (including HDL/LDL),and HbA1c, will be collected if performed during their regularly scheduled diabetic clinic visits. Throughout the course of this study, all study participant's medical records will reviewed and assessed for the occurrence of cardiac events (including hospitalizations, emergency room visits/urgent care visits, other cardiac assessments, and death) for up to 12 months. Results from cardiac testing (examples: Echo, Cardiac Catheterization, Stress Tests, etc) that may occur during the 12-month monitoring period will be collected as part of this study.

Conditions

• Diabetes Mellitus Type 2
• Cardiovascular Diseases
• Coronary Artery Disease
• Cerebrovascular Disease
• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	Hemotag	Hemotag non-invasive medical device is used to see cardiac function for DM2 patients at-home for 30 days

Timeline

• Start date: 2024-03-14
• Primary completion: 2026-03-18
• Completion: 2027-03-18
• First posted: 2024-08-23
• Last updated: 2024-08-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study